CALC

Business Context and Reporting Period

CalciMedica, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for serious illnesses driven by inflammatory processes, primarily targeting calcium release-activated calcium (CRAC) channels. The company's lead product candidate is Auxora (zegocractin). This Form 10-Q covers the quarterly period ended March 31, 2026. The company is classified as a non-accelerated filer and a smaller reporting company.

Key Financial Metrics

Note: The Net Income for Q1 2026 is primarily driven by a non-cash gain of $10.8 million from changes in the fair value of financial instruments (warrant liability and promissory note), offsetting operating losses.

Material Changes vs. Prior Period

• Profitability Shift: The company reported a net income of $4.98 million in Q1 2026, compared to a net loss of $5.04 million in Q1 2025. This reversal is attributable to a $9.1 million increase in "Other Income," specifically due to fair value adjustments on debt and warrants, rather than operational performance.
• Operating Expenses: Total operating expenses decreased by 14% to $5.61 million. Research and Development (R&D) expenses declined 17% to $3.49 million, and General and Administrative (G&A) expenses declined 6% to $2.13 million.
• Liquidity: Cash and cash equivalents decreased by $3.36 million to $8.16 million, reflecting a net cash outflow from operating activities of $4.86 million.
• Debt Structure: The fair value of the promissory note decreased by $3.0 million, and the warrant liability decreased by $7.8 million, contributing significantly to the reported net income.

Guidance, Outlook, Risks, and Unusual Items

• Going Concern: Management has expressed substantial doubt about the company's ability to continue as a going concern. Current cash resources are estimated to fund operations only into the fourth quarter of 2026. The company requires substantial additional funding to complete product development.
• Clinical Trial Pause: In January 2026, enrollment in the KOURAGE Phase 2 clinical trial for Auxora (treating acute kidney injury) was paused following a recommendation from the Independent Data Monitoring Committee due to a safety concern regarding a mortality imbalance. Consequently, Tranche 2 and Tranche 3 of the company's $32.5 million loan facility are no longer available.
• Unusual Items: The reported net income is non-recurring and non-cash in nature, driven by the revaluation of the promissory note and warrant liabilities. Operating cash flow remains negative.
• Regulatory Risks: The company faces risks related to the acceptance of clinical trial data conducted outside the U.S. (specifically in India) and the potential impact of the BIOSECURE Act on supply chains involving Chinese biotechnology companies.
• Listing Compliance: The company received notices from Nasdaq in March 2026 regarding non-compliance with the Market Value of Listed Securities (MVLS) requirement and the Minimum Bid Price requirement. The company has 180 days to regain compliance.

Investor Verification Checklist

• Cash Runway: Verify the specific timeline for cash exhaustion and the status of any ongoing fundraising efforts (e.g., ATM facility usage, private placements).
• KOURAGE Trial Status: Confirm the outcome of the FDA feedback regarding the paused KOURAGE trial and the revised study design or potential termination.
• Debt Covenants: Review the specific covenants in the Loan Agreement with Avenue Venture Opportunities Fund II, L.P., particularly regarding the impact of the trial pause on future funding tranches and default triggers.
• Nasdaq Compliance Plan: Assess the company's strategy to regain compliance with Nasdaq listing standards (MVLS and Minimum Bid Price) within the 180-day window.
• Supply Chain Exposure: Evaluate the impact of the BIOSECURE Act and potential tariffs on the manufacturing of Auxora, given reliance on single-source suppliers in China.